Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-03-03 @ 12:25 PM
Study NCT ID:
NCT00659932
Status:
COMPLETED
Last Update Posted:
2008-04-17
First Post:
2008-04-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dealing With Anxiety: A Cognitive Behavioural Program for Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-14', 'studyFirstSubmitDate': '2008-04-14', 'studyFirstSubmitQcDate': '2008-04-14', 'lastUpdatePostDateStruct': {'date': '2008-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1C (HbA1C)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Depression Anxiety Stress Scale (DASS)', 'timeFrame': '6 months'}, {'measure': 'Diabetes Quality of Life (ADDQoL)', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'cognitive behavioural therapy'], 'conditions': ['Diabetes Mellitus Type 2']}, 'descriptionModule': {'briefSummary': 'This study was designed to assess whether a cognitive behavior therapy (CBT) program for diabetes clinic patients was acceptable, improved quality of life and produced measurable change in levels of depression, anxiety and stress.', 'detailedDescription': 'Having co-morbid anxiety or depression makes it difficult to carry out the activities for diabetes selfcare. Psychological interventions have been shown to result in improvements in HbA1C and depression. Reports on psychosocial outcomes are conflicting and there are no studies of quality of life. Our diabetes outpatient population has a higher prevalence of anxiety and depression compared to the general public and this led to the development of a group CBT intervention designed to reduce anxiety as a co-morbidity of diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consenting attendees of the Hunter Area Diabetes Services RNH Diabetes Outpatient Clinic\n\nExclusion Criteria:\n\n* Accessibility problems including:\n\n * limited English\n * developmental disability\n * physical immobility\n * geographical distance\n * extreme age/frailty'}, 'identificationModule': {'nctId': 'NCT00659932', 'briefTitle': 'Dealing With Anxiety: A Cognitive Behavioural Program for Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Hunter and New England Health'}, 'officialTitle': 'Dealing With Anxiety: A Pilot Cognitive Behavioural Program for Diabetic Clinic Outpatient Attendees', 'orgStudyIdInfo': {'id': '02/03/13/3.18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Behavioral: Immediate Cognitive behavioural therapy (CBT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Behavioral: Delayed CBT']}], 'interventions': [{'name': 'Immediate Cognitive behavioural therapy (CBT)', 'type': 'BEHAVIORAL', 'description': 'The Dealing with Anxiety CBT Group Program comprises 7 group sessions: an initial five hour session followed by 6 three hour sessions over a three month period', 'armGroupLabels': ['1']}, {'name': 'Delayed CBT', 'type': 'BEHAVIORAL', 'description': 'Commencement of the CBT Group Program is delayed 3 months', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2300', 'city': 'Newcastle', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal Newcastle Hospital', 'geoPoint': {'lat': -32.92953, 'lon': 151.7801}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hunter and New England Health', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr Kerry Bowen', 'oldOrganization': 'Hunter and New England Health'}}}}